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FDA Intends to Allow Grace Period on Drug Supply Chain Security Act Marking and Verification Requirements

June 30, 2017 |FDA

The Food and Drug Administration intends to give drug manufacturers a one-year grace period to implement product identifier marking requirements under the Drug Supply Chain Security Act, it said in a draft guidance document posted June 30 (here). A requirement to “affix or imprint a product identifier to each package and homogenous case of a product” takes effect Nov. 27, 2017, but FDA does not intend to take action against manufacturers that do not do so until Nov. 26, 2018, it said. “FDA also does not intend to take action against manufacturers who do not use a product identifier to verify such product at the package level” before that date, it said. FDA will also allow a grace period for verification, wholesale distributor and dispenser verification requirements under the Drug Supply Chain Security Act, it said. Comments on the draft guidance document are due Sept. 1, FDA said (here).

FDA Allows Use of Spirulina Extract to Color Hard-Boiled Eggs

June 30, 2017 |FDA

The Food and Drug Administration is amending its color additive regulations to allow for the use of spirulina extract to “seasonally color” hard-boiled eggs “at levels consistent with good manufacturing practice,” it said (here). The change was requested by McCormick & Company. The final rule takes effect Aug. 3, 2017.

FDA Issues Draft Guidance on CGMPs for Medical Gases

June 28, 2017 |FDA

The Food and Drug Administration issued an updated draft guidance document on current good manufacturing practices for medical gases, it said (here). The updated guidance provides additional information “regarding the application of certain regulations to medical gases,” FDA said in the draft (here). “This guidance is expected to reduce the regulatory compliance burden for the medical gas industry by providing clear, up-to-date, detailed recommendations regarding CGMP issues that have been the subject of industry questions,” it said. The document supersedes draft guidance on CGMPs for medical gases issued by FDA in 2003. Comments are due Aug. 28.

New and Revised FDA Import Alerts for June 26

June 27, 2017 |FDA

On June 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts for June 23

June 26, 2017 |FDA

On June 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts for June 22

June 23, 2017 |FDA

On June 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Enforcement Report on Recalls & Field Corrections for June 21

June 23, 2017 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for June 21 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.

New and Revised FDA Import Alerts for June 21

June 22, 2017 |FDA

On June 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts for June 20

June 21, 2017 |FDA

On June 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Takes Another Step Toward Launching Third-Party Food Safety Audit Program

June 21, 2017 |FDA

The Food and Drug Administration on June 21 launched its website for organizations to apply to become accreditors of third-party certification bodies under the Food Safety Modernization Act, it said (here). "Recognized accreditation bodies will have the authority to accredit third-party 'certification bodies,' otherwise known as third-party auditors. In turn, the certification bodies (1) conduct consultative and/or regulatory food safety audits and (2) issue certifications to eligible entities that produce food for humans and animals," FDA said in a fact sheet (here). The third-party certification program allows for two types of audits -- consultative and regulatory -- the former of which does not require reports to be submitted to FDA, though records of the audits must still be maintained. Use of third-party certification bodies will be mandatory for participants in FDA’s upcoming Voluntary Qualified Importer Program, set to begin in 2019 (see 1611100028). FDA has said it expects third-party certifiers will also be relied upon by importers seeking to comply with the Foreign Supplier Verification Program regulations (see 1511190058). FDA can also require certification as a condition of entry for imported food products in limited circumstances when specific, risk-based criteria are met, it has said.